Boehringer Ingelheim has announced that the European Medicines Agency (EMA) has validated and granted accelerated assessment for its marketing authorisation application for nintedanib for treatment of idiopathic pulmonary fibrosis.
Nintedanib is an investigational small molecule tyrosine kinase inhibitor in development by Boehringer Ingelheim for idiopathic pulmonary fibrosis (IPF).
Marketing authorisation application acceptance marks the initiation of the regulatory review process for nintedanib in IPF in EU.
Boehringer Ingelheim chief medical officer Klaus Dugi said: "Acceptance of our marketing authorisation application takes us one step closer to meeting this unmet need and providing a new treatment option to patients living with IPF."
The marketing authorisation application for nintedanib has been submitted based on results from the INPULSIS-1 and INPULSIS-2 clinical trials evaluating the drug in IPF treatment.
INPULSIS-1 and INPULSIS-2 are two Phase III trials with identical design. These trials showed that nintedanib significantly slowed disease progression in the IPF patients.
Results from the two 52-week clinical trials demonstrate that nintedanib met the primary endpoint by significantly reducing the annual decline in forced vital capacity by approximately 50% compared to patients taking placebo.
Data show that nintedanib consistently slows disease progression by reducing annual decline in lung function by half.
Safety and efficacy of nintedanib have not yet been fully established. Nintedanib is also in clinical development as a treatment option for non-small cell lung cancer, ovarian cancer, colorectal cancer and hepatocellular carcinoma.
Image: High-resolution computed tomography scans of the chest of a patient with IPF. Photo: courtesy of IPFeditor.